(Reuters) – The U.S. Food and Drug Administration has issued a clinical hold on Kezar Life Sciences (NASDAQ:)’ trial of an experimental drug for lupus, the company announced on Friday.
This decision follows Kezar’s voluntary pause of the mid-stage trial of the drug, zetomipzomib, in order to review safety data in response to the deaths of four patients participating in the trial in the Philippines and Argentina.
The drug was being evaluated by Kezar in patients with active lupus nephritis, a condition that leads to inflammation and kidney damage due to the autoimmune disease lupus.
An independent study committee recommended the trial pause after identifying a common pattern of symptoms in three of the fatal cases, with the deaths occurring shortly after dosing. Additionally, a non-fatal adverse event showed a similar temporal relationship to dosing.
Kezar stated that a separate mid-stage trial evaluating zetomipzomib in patients with autoimmune hepatitis is ongoing, with no serious adverse events reported thus far.